|Publication number||US7377916 B2|
|Application number||US 10/753,693|
|Publication date||27 May 2008|
|Filing date||7 Jan 2004|
|Priority date||20 Jun 2003|
|Also published as||EP1635749A2, US7537592, US20040260276, US20040260322, WO2004112643A2, WO2004112643A3|
|Publication number||10753693, 753693, US 7377916 B2, US 7377916B2, US-B2-7377916, US7377916 B2, US7377916B2|
|Inventors||Robert I. Rudko, Mark R. Tauscher, Richard P. Yeomans, Jr.|
|Original Assignee||Plc Medical Systems, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (59), Non-Patent Citations (4), Referenced by (8), Classifications (11), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation-in-part application of U.S. patent application Ser. No. 10/600,175 filed on Jun. 20, 2003.
This invention relates to endovascular aortic valve replacement.
Currently, replacement of a malfunctioning heart valve is accomplished by a major open-heart surgical procedure requiring general anesthesia, full cardio-pulmonary bypass with complete cessation of cardio-pulmonary activity, and a long period of hospitalization and recuperation. In most cases, the native valve is resected (cut-out) and the replacement valve then installed.
As an alternative to open heart surgery, those skilled in the art have attempted to devise systems for endovascular heart valve replacement to overcome the disadvantages associated with open-heart surgery. U.S. Pat. No. 5,370,685, for example, discloses a procedure device capsule connected to a tube and delivered to the site via a guide wire introduced in the femoral artery of a patient. The device capsule houses an expandable barrier attached to balloon segments. Once the guide wire is removed and the barrier is expanded, a tissue cutting blade assembly is advanced in the tube and rotated by a DC motor to resect the existing valve. The barrier traps any debris cut by the tissue cutting blade assembly. Tissue is then suctioned out via the tube. Next, the cutting blade assembly is removed, the barrier balloons are deflated, and the barrier is brought back into the capsule and the capsule itself is removed.
Then, a valve introducer capsule is advanced to the site. The capsule houses a replacement valve and includes a pusher disk and inflatable balloon segments. After the balloon segments are inflated, the pusher disk pushes the replacement valve into position and a mounting balloon is used to expand the replacement valve and to secure it in place. Then, the introducer capsule is removed. The '685 patent is hereby incorporated herein. See also U.S. Pat. Nos. 5,545,214; 6,168,614; 5,840,081; 5,411,552; 5,370,685; and published Patent Application No. U.S. 2002/0058995 A1. These patents are also incorporated herein.
One problem with such a system is that the tissue cutting blade assembly is less than optimal and does not provide very precise cutting especially given the fact that the valve is made of both soft and hard tissue because it is heavily calcified or contains fibrotic tissue. Thus, the blades may buckle or bind as they alternately contact soft and hard tissue.
It is also presumed that pressure must be exerted on the blades. Control of this pressure and the control of the rotation rate, however, is not disclosed in the '685 patent. There is no margin for error in the resection procedure. If too much tissue is cut in certain areas, for example, the aorta can be permanently damaged. Moreover, the existing valve typically fails because of calcification of the valve resulting in stenosis or insufficiency. Using cutting blades for valve resection and an improper orientation or improper pressure on the cutting blades or the wrong rate of rotation can result in too little or too much tissue removal and/or imprecise cutting and/or blade buckling or binding as the blades alternately contact soft and hard (calcified) tissue.
Other relevant art includes the following, also included herein by this reference. Published Patent Application No. U.S. 2002/0095116 A1 discloses an aortic filter, an artery filter, and a check valve attached to the distal end of a canula for resecting an aortic valve from within the aorta. The mechanism for resecting the aortic valve, however, is not disclosed. U.S. Pat. No. 6,287,321 also discloses a percutaneous filtration catheter. U.S. Pat. No. 5,554,185 discloses an inflatable prosthetic cardiovascular valve but does not disclose any specific method of resecting the existing or native valve.
U.S. Pat. No. 6,425,916 discloses a percutaneous approach with a valve displacer for displacing and holding the native valve leaflets open while a replacement valve is expanded inside the native valve. In this way, the native valve does not need to be resected. In many cases, however, such a procedure can not be carried out due to the poor condition of the native valve. And, because the native valve occupies space, the largest aperture possible by the replacement valve may not provide sufficient blood flow.
U.S. Pat. Nos. 6,106,515 and 6,485,485, also incorporated herein by this reference, disclose various expandable laser catheter designs.
It is therefore an object of this invention to provide a more precise tissue cutting apparatus for endovascular heart valve replacement.
It is a further object of this invention to provide such a tissue cutter which is more effective than prior art blade type tissue cutters.
It is a further object of this invention to provide a tissue cutter which provides effective resection even if the valve is heavily calcified or has fibrotic tissue.
It is a further object of this invention to provide such a tissue cutter which does not require a high rate of rotation.
It is a further object of this invention to provide such a tissue cutter which eliminates the need for precise pressure control.
It is a further object of this invention to provide a mechanism which endovascularly supports the valve leaflets during resection.
The invention results from the realization that a more effective and more precise tissue cutting apparatus for endovascular heart valve replacement is effected by supporting the valve leaflets during resection using an expandable balloon advanced to the ventricular side of the valve. Various novel tissue ablation subassemblies are also disclosed as alterations to cutting blades.
This invention features an endovascular tissue removal system comprising an expandable mechanism introduceable to the ventricular side of a valve to support the leaflets of the valve in a closed position and a tissue removal device advanceable to the leaflets and configured to resect the leaflets as they are supported by the expandable mechanism.
In one embodiment, the tissue removal device includes a lumen connected to a source of ablation energy and further including an absorptive surface on the expandable mechanism for absorbing the ablation energy or a reflection surface for reflecting energy. The expandable mechanism is preferably a balloon.
In one example, the tissue removal device includes a lumen with a rotatable terminal hub advanceable in vasculature, at least one fiber extending from the hub for ablating tissue, and a second expandable mechanism connected to the fiber for biasing it into position for precisely ablating tissue as the hub rotates. There may be a plurality of fibers extending from the hub and connected to the second expandable mechanism so that the plurality of fibers can be spread apart for tissue ablation and also collapsed together for vascular insertion and removal. The second expandable mechanism is preferably a circumferentially expanding balloon. There may be two balloons, one inside and one outside of the distal end of the fiber. Typically, the lumen includes an inflation conduit therein connected to the balloon. The fiber may be an optical fiber connected to a source of laser energy or a waveguide connected to a source of laser energy.
Further included may be a tissue trap device surrounding the expandable mechanism. Typically, the fiber includes an angled distal portion. Also included may be a mirror for redirecting the ablation energy.
In another embodiment, the tissue removal device includes a lumen including a distal steerable tip portion extending from a joint portion, registration means for holding the joint portion fixed in place in the vasculature, and a source of ablation energy in communication with the lumen whereby tissue can be resected by ablation energy as the tip portion is steered within the vasculature. In one example, the registration means includes a second inflatable balloon about the joint portion, the source of ablation energy is a laser, the distal steerable tip portion includes a deflectable tip catheter, and there is an optical fiber inside the deflectable tip catheter and connected to the laser. An expandable barrier may be provided for trapping any debris resected.
Another tissue removal device includes a fiber advanceable within vasculature to ablate tissue, an outer expandable balloon, and an inner expandable balloon spaced from the outer expandable balloon forming a space within which the fiber travels to resect tissue. In one version, the outer expandable balloon is a portion of a tissue trap device and the distal end of the fiber is angled.
A method of endovascularly removing a heart valve in accordance with this invention comprises introducing an expandable mechanism to the ventricular side of the valve, expanding the mechanism to support the leaflets of the valve in a closed position, and resecting the leaflets of the valve as they are supported by the expandable mechanism.
Resecting typically includes directing ablative energy at the leaflets. A lumen is introduced within the vasculature of a patient to a situs proximate a heart valve to be resected, ablative energy is introduced into the lumen, and the lumen is rotated to resect the heart valve.
In another method, a lumen is endovascularly introduced with a distal steerable tip portion to a position proximate a valve to be resected, the lumen is registered in place in the vasculature, ablation energy is directed through the lumen, and the distal steerable tip portion is steered to resect the valve.
Other objects, features and advantages will occur to those skilled in the art from the following description of a preferred embodiment and the accompanying drawings, in which:
Aside from the preferred embodiment or embodiments disclosed below, this invention is capable of other embodiments and of being practiced or being carried out in various ways. Thus, it is to be understood that the invention is not limited in its application to the details of construction and the arrangements of components set forth in the following description or illustrated in the drawings.
But, the prior art teaches resection of the native valve tissue by tissue cutter 40,
As shown in
The problem is so profound that some skilled in the art have attempted to eliminate native valve resection and instead theorize that a prosthetic valve can be expanded directly within native valve 12 (or 14) using a valve displacer to hold the native valve open. As delineated above, however, due to the condition of the native valve, such a procedure is not always possible or effective.
In the subject invention, more precise tissue cutting is effected even if native valve 12,
Lower balloon 200 is disposable on the ventricular side of the heart valve under leaflets 204 and 206. Balloon 200 is connected to an inflation conduit which extends within multi-lumen catheter 100. An outer suction conduit may include a port for withdrawing tissue. Balloon 200 performs several important functions. First, it supports leaflets 204 and 206 of the valve as they are pushed closed by the tissue removal device before cutting for more accurate cutting. Balloon 200 with laser energy absorption or reflection layer 212 also prevents inadvertent cutting of any portion of mitral valve 216.
A complete system may include an expandable barrier such as barrier 30,
In this way, the problems associated with prior art blade type tissue cutters are eliminated and tissue cutting is far more precise by the use of optical fiber 110 within deflectable tip catheter 100 and expandable balloon 116 which registers the assembly inside the heart for resection by laser ablation as the deflectable tip portion steers the distal end of optical fiber 110.
In the embodiment of
In another embodiment, the endovascular tissue removal device 480,
In this way, the problem associated with prior art blade type tissue cutters are eliminated and tissue cutting is more precise by the use of electromagnetic energy in combination with the expandable balloon which spreads apart the plurality of optical fibers 488 and registration balloon 498 which registers the assembly inside the heart for resection typically as hub 484 rotates. The distal ends of optical fibers 488 are preferably precisely oriented to resect only valve tissue as shown by vectors 481 and 483,
A more complete system is shown in
In still another embodiment, optical fiber 488,
In the embodiment of
In the embodiment of
Although specific features of the invention are shown in some drawings and not in others, this is for convenience only as each feature may be combined with any or all of the other features in accordance with the invention. The words “including”, “comprising”, “having”, and “with” as used herein are to be interpreted broadly and comprehensively and are not limited to any physical interconnection. Moreover, any embodiments disclosed in the subject application are not to be taken as the only possible embodiments.
Other embodiments will occur to those skilled in the art and are within the following claims:
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US467852||12 Oct 1891||26 Jan 1892||Vania|
|US1858544||4 Oct 1928||17 May 1932||Erickson Carl G||Caliper|
|US2267110||18 Jul 1940||23 Dec 1941||Kinley||Surveying caliper|
|US3271869||15 Jul 1965||13 Sep 1966||Nathaniel C Ratner||Precision spacing dividers|
|US3505987||17 Mar 1967||14 Apr 1970||Medrad Inc||Intra-aortic heart pump|
|US3533166||17 Sep 1968||13 Oct 1970||A J Spedale||Pipe y locator|
|US3555689||19 Dec 1968||19 Jan 1971||Schlumberger Technology Corp||Centralizing and well-calipering apparatus for well tools|
|US3772794||22 Dec 1971||20 Nov 1973||Hercules Inc||Borehole measuring device|
|US4213246||20 Jul 1978||22 Jul 1980||Stevens Daniel M||Collapsible and adjustable gage apparatus|
|US4407157||5 Aug 1981||4 Oct 1983||Dresser Industries, Inc.||Apparatus for measuring the diameter of a borehole|
|US4411648||11 Jun 1981||25 Oct 1983||Board Of Regents, The University Of Texas System||Iontophoretic catheter device|
|US4587975||2 Jul 1984||13 May 1986||Cardiac Pacemakers, Inc.||Dimension sensitive angioplasty catheter|
|US5074871||7 Dec 1989||24 Dec 1991||Evi Corporation||Catheter atherotome|
|US5171248||27 Feb 1991||15 Dec 1992||Intermedics Orthopedics, Inc.||Medullary caliper|
|US5176693||11 May 1992||5 Jan 1993||Interventional Technologies, Inc.||Balloon expandable atherectomy cutter|
|US5238005||18 Nov 1991||24 Aug 1993||Intelliwire, Inc.||Steerable catheter guidewire|
|US5275169||15 Jan 1992||4 Jan 1994||Innovation Associates||Apparatus and method for determining physiologic characteristics of body lumens|
|US5356382||23 Oct 1992||18 Oct 1994||Applied Medical Research, Inc.||Percutaneous tract measuring and forming device|
|US5366490||22 Dec 1993||22 Nov 1994||Vidamed, Inc.||Medical probe device and method|
|US5370685||16 Jul 1991||6 Dec 1994||Stanford Surgical Technologies, Inc.||Endovascular aortic valve replacement|
|US5398691||3 Sep 1993||21 Mar 1995||University Of Washington||Method and apparatus for three-dimensional translumenal ultrasonic imaging|
|US5411552||14 Jun 1994||2 May 1995||Andersen; Henning R.||Valve prothesis for implantation in the body and a catheter for implanting such valve prothesis|
|US5428903||23 Mar 1994||4 Jul 1995||Pocci; Silvano||Measuring instrument|
|US5465732||31 Mar 1992||14 Nov 1995||Boston Scientific Corporation||Fluoroscopically viewable multifilar calibrated guidewire and method of measuring occlusions with calibrated guidewires|
|US5499995||25 May 1994||19 Mar 1996||Teirstein; Paul S.||Body passageway closure apparatus and method of use|
|US5545214 *||4 Mar 1994||13 Aug 1996||Heartport, Inc.||Endovascular aortic valve replacement|
|US5554185||18 Jul 1994||10 Sep 1996||Block; Peter C.||Inflatable prosthetic cardiovascular valve for percutaneous transluminal implantation of same|
|US5562665||6 Jun 1995||8 Oct 1996||Young; Merry A.||Method for reaming an intramedullary canal|
|US5607462||7 Jul 1994||4 Mar 1997||Cardiac Pathways Corporation||Catheter assembly, catheter and multi-catheter introducer for use therewith|
|US5693043 *||3 Apr 1990||2 Dec 1997||Massachusetts Institute Of Technology||Catheter for laser angiosurgery|
|US5725523 *||29 Mar 1996||10 Mar 1998||Mueller; Richard L.||Lateral-and posterior-aspect method and apparatus for laser-assisted transmyocardial revascularization and other surgical applications|
|US5728123 *||26 Apr 1995||17 Mar 1998||Lemelson; Jerome H.||Balloon actuated catheter|
|US5830210 *||21 Oct 1996||3 Nov 1998||Plc Medical Systems, Inc.||Catheter navigation apparatus|
|US5840081||19 Feb 1997||24 Nov 1998||Andersen; Henning Rud||System and method for implanting cardiac valves|
|US5885244||14 May 1997||23 Mar 1999||Cordis Corporation & University Of Miami||Synchronous, pulsatile angioplasty system|
|US5899915||17 Oct 1997||4 May 1999||Angiotrax, Inc.||Apparatus and method for intraoperatively performing surgery|
|US5957916 *||7 Jun 1995||28 Sep 1999||The Trustees Of Columbia University In The City Of New York||Myocardial revascularization through the endocardial surface using a laser|
|US6010511||18 Feb 1999||4 Jan 2000||Murphy; Richard||Lesion diameter measurement catheter and method|
|US6023638 *||22 May 1998||8 Feb 2000||Scimed Life Systems, Inc.||System and method for conducting electrophysiological testing using high-voltage energy pulses to stun tissue|
|US6033359||27 Oct 1998||7 Mar 2000||Asahi Kogaku Kogyo Kabushiki Kaisha||Endoscopic length-measuring tool|
|US6056743 *||5 Mar 1998||2 May 2000||Scimed Life Systems, Inc.||Percutaneous myocardial revascularization device and method|
|US6081737||11 Aug 1998||27 Jun 2000||Shah; Ajit||Apparatus for vascular mapping and methods of use|
|US6106515||13 Aug 1998||22 Aug 2000||Intraluminal Therapeutics, Inc.||Expandable laser catheter|
|US6110200||25 Sep 1998||29 Aug 2000||St. Jude Medical, Inc.||Adjustable sizing apparatus|
|US6168614||20 Feb 1998||2 Jan 2001||Heartport, Inc.||Valve prosthesis for implantation in the body|
|US6287321||16 Nov 1999||11 Sep 2001||Embol-X, Inc.||Percutaneous filtration catheter for valve repair surgery|
|US6423055||14 Jul 1999||23 Jul 2002||Cardiofocus, Inc.||Phototherapeutic wave guide apparatus|
|US6425916||10 Feb 1999||30 Jul 2002||Michi E. Garrison||Methods and devices for implanting cardiac valves|
|US6450976||12 Mar 2001||17 Sep 2002||Accumed Systems, Inc.||Apparatus for measuring the length and width of blood vessels and other body lumens|
|US6485485||3 May 2000||26 Nov 2002||Intraluminal Therapeutics, Inc.||Expandable laser catheter|
|US6517515||20 Jan 1999||11 Feb 2003||Scimed Life Systems, Inc.||Catheter having variable size guide wire lumen|
|US6560889||1 Nov 2000||13 May 2003||Baker Hughes Incorporated||Use of magneto-resistive sensors for borehole logging|
|US6616629 *||14 Jun 1999||9 Sep 2003||Schneider (Europe) A.G.||Medical appliance with centering balloon|
|US6656204 *||31 Oct 2001||2 Dec 2003||Embol-X, Inc.||Adjustable blood filtration system|
|US6764453||8 May 2002||20 Jul 2004||Sherwood Services Ag||Stoma measuring device|
|US6767362 *||28 Jun 2002||27 Jul 2004||Edwards Lifesciences Corporation||Minimally-invasive heart valves and methods of use|
|US6908478||5 Dec 2001||21 Jun 2005||Cardiac Dimensions, Inc.||Anchor and pull mitral valve device and method|
|US20020058995||23 Oct 2001||16 May 2002||Stevens John H.||Endovascular aortic valve replacement|
|US20020095116||14 Dec 2001||18 Jul 2002||Strecter Richard B.||Apparatus and method for replacing aortic valve|
|1||Cardima Naviport Deflectable Tip Guiding Catheter Brochure, Oct. 2001.|
|2||U.S. Appl. No. 10/447,532, filed May 29, 2003, Rudko et al.|
|3||U.S. Appl. No. 10/600,175, filed Jun. 20, 2003, Rudko et al.|
|4||U.S. Appl. No. 10/628,794, filed Jul. 28, 2003, Rudko et al.|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US8496655||6 Apr 2010||30 Jul 2013||Michael J. O'Donnell||System and method for resecting a valve|
|US8673001 *||11 Jan 2008||18 Mar 2014||StJude Medical, Cardiology Division, Inc.||Methods for controlling the internal circumference of an anatomic orifice or lumen|
|US8758372||21 May 2007||24 Jun 2014||St. Jude Medical, Cardiology Division, Inc.||Implantable devices for controlling the size and shape of an anatomical structure or lumen|
|US8778021||3 Sep 2010||15 Jul 2014||St. Jude Medical, Cardiology Division, Inc.||Post-operative adjustment tool, minimally invasive attachment apparatus, and adjustable tricuspid ring|
|US8808371||22 Jan 2010||19 Aug 2014||St. Jude Medical, Cardiology Division, Inc.||Post-operative adjustment tool, minimally invasive attachment apparatus, and adjustable tricuspid ring|
|US9107750||3 Jan 2008||18 Aug 2015||St. Jude Medical, Cardiology Division, Inc.||Implantable devices for controlling the size and shape of an anatomical structure or lumen|
|US20060018528 *||27 Apr 2005||26 Jan 2006||Northwestern University||Imaging, diagnostic, and therapeutic devices and methods of use thereof|
|US20080109076 *||11 Jan 2008||8 May 2008||Mitralsolutions, Inc.||Methods for controlling the internal circumference of an anatomic orifice or lumen|
|U.S. Classification||606/15, 606/7|
|International Classification||A61B18/24, A61B17/00, A61B17/22, A61B18/18|
|Cooperative Classification||A61B2017/22097, A61B2017/00243, A61B2017/22051, A61B18/24|
|7 Jan 2004||AS||Assignment|
Owner name: PLC MEDICAL SYSTEMS, INC., MASSACHUSETTS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:RUDKO, ROBERT I.;YEOMANS, RICHARD P., JR.;TAUSCHER, MARKR.;REEL/FRAME:014883/0926
Effective date: 20031230
|9 Jan 2012||REMI||Maintenance fee reminder mailed|
|27 May 2012||LAPS||Lapse for failure to pay maintenance fees|